Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL
PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名:Junning Cao
- 电话号码:+86-21-64175590
- 邮箱:cao_junning@126.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
- 2. Age≥18, ≤70 years
- 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
- 4. No previous systemic treatment before enrollment.
- 5. At least one measurable lesions according to LUGANO 2014 criteria.
- 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- 7. Life expectancy ≥3 months.
- 8. Ineligible or decline to receive autologous stem cell transplantation (ASCT).
- 9. Adequate main organ function defined as the following required baseline laboratory data: Absolute neutrophil count (ANC)≥1.5×109/L without given G-CSF within 14 days; Platelet count (PLT)≥75×109/L without given transfusion with 14 days; Hemoglobin (HB)≥8g/dL without given transfusion or erythropoietin; Total bilirubin (TBIL)≤1.5X upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5X ULN; Serum creatinine (Scr)≤1.5X ULN; Left ventricular ejection fraction (LVEF)≥50%; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age was defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
- 10.If there is a risk of pregnancy, all participants (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for entire treatment period up to 120 days after the last dose of investigational drug (or 180 days after chemotherapeutic drug).
Exclusion Criteria:
- 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
- 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
- 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
- 4. Patients undergo interventional clinical trials.
- 5. Concurrent lymphoma with CNS invasion.
- 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- 7. Known allergy to the active ingredients or excipients of IBI376 and CHOP regimens.
- 8. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- 9. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody.
- 10. Received live vaccine within 30 days prior to initial investigational drug administration (day 1 of cycle 1) (Note: inactivated virus vaccine for injection is allowed within 30 days prior to initial administration, but live attenuated vaccine is not allowed).
- 11. Pregnant or breastfeeding women.
- 12. Any serious uncontrolled systemic disease.
- 13. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:PI3Kδ inhibitor Parsaclisib plus CHOP
Phase Ib (Explored the appropriate dose of Parsaclisib in combination with CHOP) Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. CHOP was given at the standard dose, 21 days per cycle Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib day 1-14 of each cycle, as well as CHOP at standard dose for 6 cycles. Maintain treatment: Parsaclisib maintenance (2.5mg po, qd) will be performed on CR or PR patients after 6 cycles of induction therapy until disease progression, death, unacceptable toxicity, withdrawal of informed consent, or the investigator's decision or initiation of new antitumor therapy. The maximum maintenance period of parsaclisib is 24 months. |
Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib. Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years.
其他名称:
Cyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
3-year EFS
大体时间:From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
|
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
|
From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
血液学和非血液学毒性
大体时间:整个治疗期间,长达6个月
|
根据 CTCAE v5.0 评估,出现治疗相关不良事件的参与者人数
|
整个治疗期间,长达6个月
|
CRR
大体时间:at the end of Cycle 6 (each cycle is 21 days)
|
the ratio of numbers of patients with complete response to all the participants receiving treatment
|
at the end of Cycle 6 (each cycle is 21 days)
|
ORR
大体时间:at the end of Cycle 6 (each cycle is 21 days)
|
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
|
at the end of Cycle 6 (each cycle is 21 days)
|
EFS
大体时间:From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
|
the period from the date of patients sign informed consent to the observed event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment
|
From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
|
OS
大体时间:From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
|
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
|
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
|
合作者和调查者
调查人员
- 首席研究员:Junning Cao、Fudan University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
PTCL的临床试验
-
Anne Beaven, MDBoehringer Ingelheim; National Comprehensive Cancer Network撤销
-
The First Hospital of Jilin University招聘中
-
University of VirginiaMerck Sharp & Dohme LLC; Otsuka Pharmaceutical Development & Commercialization, Inc.招聘中
-
Fondazione Italiana Linfomi - ETS主动,不招人外周 T 细胞淋巴瘤 (PTCL) | PTCL-NOS | 血管免疫母细胞性 T 细胞淋巴瘤 (AITL) | ALK- 间变性大细胞淋巴瘤 (ALCL) | T 滤泡辅助细胞来源的淋巴结外周 T 细胞淋巴瘤意大利
-
Shanghai YingLi Pharmaceutical Co. Ltd.招聘中
Parsaclisib的临床试验
-
Incyte Corporation主动,不招人淋巴瘤比利时, 美国, 法国, 以色列, 意大利, 英国, 德国, 西班牙, 波兰, 澳大利亚, 阿根廷, 丹麦
-
UNC Lineberger Comprehensive Cancer CenterIncyte Corporation撤销乳腺癌 | 乳腺肿瘤 | 三阴性乳腺癌 | HER2阳性乳腺癌
-
Incyte Corporation主动,不招人淋巴瘤美国, 西班牙, 法国, 英国, 捷克语, 以色列, 比利时, 意大利, 德国, 波兰, 丹麦
-
Incyte Corporation招聘中B细胞恶性肿瘤美国, 西班牙, 比利时, 日本, 意大利, 法国, 英国, 以色列, 火鸡, 挪威, 大韩民国, 捷克语, 瑞典, 奥地利, 波兰, 匈牙利, 丹麦